Approval Probability
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Adjusted LOA
ML Risk
AMG 827 · 1 trial · 1 indication
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| AMG 827 140 mg | EXPERIMENTAL | Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| AMG 827 210 mg | EXPERIMENTAL | Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| AMG 827 280 mg | EXPERIMENTAL | Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| Name | Type | Description |
|---|---|---|
| AMG 827 | DRUG | SC injection. |
| Placebo | DRUG | SC injection. |
Inclusion Criteria: * Men or women 18 to 65 years of age * Percent of predicted FEV1 ≥ 50% and ≤ 80% * At least 12% reversibility over pre-bronchodilator FEV1 * Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent * Ongoing asthma symptoms with ACQ composite score ≥...
AMG 827 is an investigational small molecule being developed for the treatment of asthma. It is intended for patients with inadequately controlled asthma, as evaluated in a clinical study. The drug is currently in Phase 2 clinical development.
AMG 827 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
AMG 827 is in Phase 2 clinical development. A Phase 2 study has been completed to evaluate dosing of the drug in subjects with inadequately controlled asthma. The drug is investigational and has not been approved by regulatory authorities.
AMG 827 has one completed Phase 2 clinical trial, identified as NCT01199289. The study, titled 'A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma,' enrolled 315 participants across multiple countries, including the United States, Austria, Belgium, Canada, Finland, Hungary, Netherlands, Poland, Russia, and South Korea.
Yes, the Phase 2 clinical trial of AMG 827 was a randomized, double-blind, placebo-controlled study. This design helps assess the drug's effects compared to a placebo in patients with inadequately controlled asthma.
The Phase 2 trial of AMG 827 enrolled 315 participants and has been completed. The study included adults aged 18 years and older of all sexes, and it did not involve healthy volunteers. The trial was conducted in multiple countries across North America, Europe, and Asia.